CooperSurgical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0098-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Colpo-Pneumo Occluder, Part CPO-6

Product Classification:

Class II

Date Initiated: September 4, 2018

Date Posted: October 17, 2018

Recall Number: Z-0098-2019

Event ID: 80993

Reason for Recall:

The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

Status: Terminated

Product Quantity: 32538

Code Information:

Lots 244131, 244132, 244670, 244671, 244887, 244888, 244889, 244890, 245228, 245325, 245326, 245327, 245613, 245614, 245615, 245976, 245977, 245978, 245979, 246810, 246811, 247262, 247608, 24 7609, 247610, & 248112

Distribution Pattern:

The products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The products were distributed to the following foreign countries: Canada, Columbia, Czech Republic, Germany, Hong Kong, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Russian Federation, Singapore, Slovenia, South Korea, Spain, Switzerland, UAE, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated